Methods and apparatuses for fluoro-less or near fluoro-less percutaneous surgery access

ABSTRACT

A needle access assembly and method for obtaining percutaneous needle access with little or no fluoroscopy. The method can include selecting a target for percutaneous access, directing a laser guide at a desired needle-insertion angle and in line with the selected target, aligning the needle access assembly with the laser, and inserting the needle into the target.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This present application is a continuation of co-pending U.S.application Ser. No. 14/295,148, filed Jun. 3, 2014, titled METHODS ANDAPPARATUSES FOR FLUORO-LESS OR NEAR FLUORO-LESS PERCUTANEOUS SURGERYACCESS, which claims priority benefit under 35 U.S.C. §119(e) to U.S.Provisional Application No. 61/830,585, filed Jun. 3, 2013, titledMETHOD FOR FLUORO-LESS OR NEAR FLUORO-LESS PERCUTANEOUS SURGERY ACCESS,and U.S. Provisional Application No. 61/902,090, filed Nov. 8, 2013,titled METHOD FOR FLUORO-LESS OR NEAR FLUORO-LESS PERCUTANEOUS SURGERYACCESS, both of which are hereby incorporated by reference in theirentirety.

Any and all applications for which domestic priority claim is identifiedin the Application Data Sheet as filed with the present application arehereby incorporated by reference under 37 CFR 1.57.

BACKGROUND

1. Field

The present disclosure relates to percutaneous surgery access.

2. Description of the Related Art

Percutaneous access is a commonly used step for the treatment and ortesting of a variety of diseases and conditions in a plethora ofsurgical and clinical procedures. An initial step in many forms ofpercutaneous surgery is the insertion of a wire for later access intothe inner portion of a lumen, space, viscous, or organ. An example ofthis type of access could be placement of a needle through the skin intothe kidney for access into one of the calices of the kidney. This stepof the percutaneous procedure is often one of the most difficult stepsand often requires real-time, imaging guidance with ultrasound, CT, orfluoroscopy.

SUMMARY

Conventional techniques for needle placement require the use ofcontinuous fluoroscopy during the insertion of the needle into thecollecting system. Due to the depth of the tissues surrounding thekidney and the variation of the renal position caused by ventilation thesurgeon is asked to hit a small moving target positioned deep inside thebody and slight imprecision in needle positioning may lead to completefailure to access the desired space. Subsequently, surgeons are requiredto grasp a needle using either their hands (placing their hands directlyinside the fluoroscopy beam), or using a needle holder or device forholding the needle (decreasing their control and ability to perceivetactile subtle cues regarding tissue densities).

Fluoroscopy guidance accounts for a substantial percentage of theprocedural radiation exposure to the patient as well as the surgicalteam. Every patient poses a different challenge and significant amountsof fluoroscopy can be used to navigate the trocar needle through thepatient's anatomy. During needle placement, the amount of fluoroscopyrequired to obtain access is often several minutes and may be greaterthan 60 minutes of fluoroscopy time. 60 minutes (60 mSy) of fluoroscopymay be associated with significant radiation exposure and depending uponthe location of the fluoroscopy beam and the size of the patient mayexceed the recommended yearly occupational exposures of radiation. Thedeterministic effects of radiation occur quickly following exposure andmay include sterility, cataracts, skin erythema, and/or damage to theblood production system, intestinal function, or neurologic function. Incontrast, the stochastic effects of radiation are not directly dosedependent and may occur at any time following radiation exposure and mayinclude genetic damage, cancer, and mental effects. High levels ofradiation exposure have been recognized as a potential carcinogenic riskto the patient since the high-energy radiation may cause DNA mutation.It has been shown that a few minutes of fluoroscopy time at standardsettings will confer a 1/1,000 risk of developing fatal cancer. Forevery 1000 patients exposed to even 10 mSv of radiation, one of thosewill develop cancer as a result. See Sodickson, A., Baeyens, P. F.,Andriole, K. P. et al., Recurrent CT, cumulative radiation exposure, andassociated radiation-induced cancer risks from CT of adults. Radiology,251: 175, 2009. Further, fluoroscopy exposure is also known to have acumulative effect over time, increasing the risk of stochastic effectson both the patient and the staff members, including the physician. Asthere is no safe lower limit (no safe threshold), below which no riskfor cancer will occur and since the higher the exposure the greater therisk, it is important to decrease the radiation exposure of patientsduring percutaneous access.

Certain aspects of the present disclosure are directed toward a devicethat, when paired with a guidance system, may it be a laser or any imageguided methods of needle placement such as ultrasound, ionizingradiation (fluoroscopy, plain film x-ray), computerized tomography, ormagnetic resonance imaging, can deliver accurate and precise placementof a needle. When the device is aligned between the imaging system andthe target, the device provides visual confirmation of alignment to theuser and “paints” the target to facilitate precise insertion of atrocar-cannula needle.

Certain aspects of the present disclosure are directed toward a methodof obtaining percutaneous needle access. The method can includeselecting a calix for percutaneous access; positioning a flexibleureteroscope in the selected calix; directing a laser guide at a desiredneedle-insertion angle and in line with a tip of the uretero scope;aligning a needle with the laser and the ureteroscope tip; and insertingthe needle into the selected calix. In certain aspects, if necessary,fluoroscopy can be applied for less than about ten seconds. In otheraspects, this method and devices may allow incremental reduction inradiation exposure of 5-10%. In other aspects, this reduction might bebetween 5 and 99%.

The above-mentioned method can include delivering an instrument to theselected calix. The instrument can be configured to facilitate theinsertion of the needle into the selected calix. In certain aspects, theinstrument can be identifiable under ultrasound. In certain aspects, theinstrument can be a balloon catheter. In certain aspects, the instrumentcan be a basket catheter.

Any feature, structure, or step disclosed herein can be replaced with orcombined with any other feature, structure, or step disclosed herein, oromitted. Further, for purposes of summarizing the disclosure, certainaspects, advantages, and features of the inventions have been describedherein. It is to be understood that not necessarily any or all suchadvantages are achieved in accordance with any particular embodiment ofthe inventions disclosed herein. No aspects of this disclosure areessential or indispensable.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. Furthermore, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure.

FIG. 1 illustrates an exemplary balloon catheter that can be used withthe methods described herein.

FIG. 2 illustrates an exemplary basket catheter that can be used withthe methods described herein.

FIG. 3 illustrates an exemplary embodiment of a needle.

FIG. 4 illustrates a top view of the needle shown in FIG. 3 havingconcentric rings to provide a target for laser guidance.

FIGS. 5-7 illustrate a training model for percutaneous surgical accesstraining

FIGS. 8A-8D illustrate a method for laser-guided percutaneous access.

FIG. 9 illustrates a profile view of exemplary embodiment of a needleassembly that can be used with the methods described herein.

FIG. 9A illustrates the needle assembly shown in FIG. 9 in anilluminated configuration.

FIG. 10 illustrates a side view of the trocar needle and a cannula ofthe needle assembly shown in FIG. 9.

FIG. 11 illustrates a perspective view of the trocar needle and thecannula shown in FIG. 10.

FIG. 12 illustrates a cross-sectional view of a cap and a proximalportion of an embodiment of a trocar needle.

FIG. 13A illustrates a cross-sectional view of an embodiment of a trocarneedle having a reflective coating plate.

FIG. 13B illustrates a cross-sectional view of an embodiment of a trocarneedle having a dome reflector.

FIG. 14A illustrates another embodiment of a cap and a trocar needle.

FIG. 14B illustrates a perspective view of a needle access assemblyhaving the trocar needle shown in FIG. 14A and a cannula.

FIG. 14C illustrates a side view of the needle access assembly shown inFIG. 14B.

FIG. 15A illustrates a side view of another embodiment of a needleaccess assembly having a trocar needle and a cannula.

FIG. 15B illustrates a distal end view of the trocar needle shown inFIG. 15A.

FIG. 15C illustrates a proximal end view of the trocar needle shown inFIG. 15A.

FIG. 15D illustrates a partial cross-section of a proximal portion ofthe trocar needle shown in FIG. 15A.

FIG. 16 illustrates a perspective view of an exemplary embodiment of theassembly indicating that the assembly is properly aligned.

FIG. 17 illustrates a perspective view of the assembly shown in FIG. 16indicating that the assembly is not properly aligned.

FIG. 18A illustrates a side view of an exemplary embodiment of acannula.

FIG. 18B illustrates an end view of the cannula shown in FIG. 18A.

FIG. 18C illustrates a perspective view of the cannula shown in FIG.18A.

DETAILED DESCRIPTION

The following discussion is presented to enable a person skilled in theart to make and use one or more embodiments of the invention. Thegeneral principles described herein may be applied to embodiments andapplications other than those detailed below without departing from thespirit and scope of the invention. Therefore the present disclosure isnot intended to be limited to the embodiments shown, but is to beaccorded the widest scope consistent with the principles and featuresdisclosed or suggested herein.

Given the risks associated with fluoroscopy exposure described above,there is a need to reduce procedural ionizing radiation. One suchsolution is to reduce fluoroscopy use during percutaneous access totissue, while simultaneously maintaining accurate needle placement. Assuch, there is a need for a device that will allow precision andaccuracy without continuous fluoroscopy use for recurrent visualization.

The devices and methods described herein are designed to simplifyprocedures for percutaneous access and significantly reduce radiationexposure to the surgeon, patient, and staff members. Although thedisclosure below is discussed in connection with the kidneys, themethods and devices described herein can be used to obtain access toother structures, lumens, organs, and spaces.

Method of Inserting an Ureteroscope without Image Guidance

Placing a needle into the kidney for renal access for stone surgery willbe used as an example of this technique. However, similar concepts andprinciples would also apply to other procedures, such as placing probesinto the kidney to treat a renal cancer, placing access into an infectedfluid collection for drainage of an abscess, placing tubes into anyspace to serve as a drain, (i.e., pleural space, peritoneal drain,cholecystectomy drain, bladder drain, lymphocele drain, pericardialspace, etc.).

In describing the percutaneous access into the kidney as an example, thepatient can be positioned into a prone and split-legged position toallow simultaneous access into the kidney and the urethra. Using aflexible cystoscope, the surgeon can place a guide wire into the kidneyto allow later insertion of an ureteroscope into the kidney. Afterpositioning the first guide wire, the surgeon can optionally position adual lumen type catheter in the kidney to allow the placement of asecond guide wire, so there can be both a working wire and a safety wirepositioned in the kidney. In certain aspects, the guide wires can beplaced into the kidney in a retrograde fashion using no image guidanceat all. The two guide wire lengths can be compared to confirm that bothwires were correctly positioned in the kidney.

The working and/or safety guide wires can include one or more of thefollowing features. In certain aspects, the guide wire can be anangle-tipped guide wire that has a lubricious coating to allow it toslip easily above any ureteral obstruction. In certain aspects, theguide wire can include one or more features to facilitate visualization.For example, the guide wire can be designed to produce a highlyechogenic profile allowing it to be easily visualized using ultrasound.In one configuration, the shaft may be rounded at the tip to alloweasier insertion but have a flattened shape proximal to the tip (e.g.,about 1 to 5 cm proximal to the tip of the wire) to allow the wire to bemore easily seen under ultrasound guidance. The flattened surfaces ofthe wire may reflect the acoustic beams back at a similar angle to allowthe wire to be easily seen under ultrasound. This wire may also beeasily seen under very low dose fluoroscopy levels. As another example,the guide wire can include one or more radiopaque markers to enhancefluoroscopic visualization. The guide wire may have interval marks(e.g., placed every one cm) to allow insertion of these wires underendoscopic visualization. For example, the wire might be black withwhite markings identifying the distances. As another example, the wirecould be white with blue markings identifying the length marks. Thecolors could be any color that would allow easy identificationendoscopically and externally. In certain aspects, the guide wire caninclude a nitinol core and/or a PTFE coating. In certain aspects, theguide wire may include a lubricious coating to allow easy insertion. Incertain aspects, the wire could include a retractable square outersheath through which the guide wire could be placed into the kidney toallow appropriate placement and then the acoustically dense sheathpassed over the wire to allow even the tip to be seen easily underultrasound. In certain aspects, the guide wire could be etched with anacoustically dense surface to allow the wire to be seen easily underultrasound guidance. In one configuration, the guide wire might be anAmplatz extra stiff type wire that is floppy at both ends to allow theinsertion of the flexible ureteroscope without trauma to theureteroscope or the kidney. In certain aspects, the guide wire can be astandard 0.035 or 0.038 Teflon-coated guide wire or a lubriciouslycoated guide wire.

The surgeon can advance a flexible ureteroscope over the working wireinto the ureter using a fluoro-less technique. The technique forinsertion of the ureteroscope is particularly important to prevent themigration of ureteral stones outside of the ureter, and to facilitatecorrect positioning of the ureteroscope. In general, if recent imagingshows no ureteral stones the ureteroscope will be placed over theworking wire and advanced until the ureteroscope tip is in the proximalureter a distance of 15 to 20 cm in a female and 30-35 cm in a male withnormal sized phallus. If recent imaging shows a mid-ureteral stone, theflexible ureteroscope will only be advanced into the distal ureter. Ifrecent imaging shows only a distal ureteral stone, the flexibleureteroscope will be advanced just through the ureteral orifice.

The actual passage of the ureteroscope may occur in several ways. In onemethod, the surgeon advances the ureteroscope tip over the wire whilethe assistant holds the handle of the ureteroscope and the wire in asteady and fixed position. This allows the surgeon to delicately feelthe tactile feedback from the points of resistance as the ureteroscopeis advanced over the wire including the urethral sphincter, bladderneck, and ureteral orifice. If resistance is met at the appropriatedepth for the ureteral orifice (and the ureteroscope does not progress),the ureteroscope is pulled back 2-3 cm and rotated 90 degrees andanother attempt at advancement is made. If this is not successful, theureteroscope can be pulled back another 2-3 cm and rotated in the samedirection another 90 degrees before another attempt is made. This isrepeated until the ureteroscope has returned back to the originalstarting position. If the ureteroscope has rotated 360 degrees and therehas been no passage through the ureteral orifice a Foley will beinserted into the bladder in order to empty the bladder and the processrepeated in its entirety.

In another method, the ureteroscope may be passed with the light cordand camera connected so that some subtle visual details may be obtainedas the ureteroscope is advanced up the ureter.

In a third method the ureteroscope might be advanced using a “barenaked” technique up the ureter without the use of a safety wire and theureteroscope used as the safety channel itself. In this technique normalsaline or any other irrigation fluids would be injected under pressureto provide visualization of the important anatomic structures. If theureteroscope has difficulty engaging the ureteral orifice a guide wirecould be inserted into the ureteral orifice to help engage theureteroscope tip into the ureter and the ureteroscope could then beadvanced into the ureter under direct vision.

With all the techniques, once the ureteroscope was positioned in theureter it would slowly be advanced up the ureter in a retrograde fashionfrom the point of insertion under direct vision. This flexibleureteroscope would then be advanced slowly in a retrograde fashion fromthe point of insertion either until a stone was encountered or until therenal calices were identified.

The next step in the ureteroscopic-assisted form of the Laser DARRTtechnique is for the surgeon under direct endoscopic vision to selectthe desired calix for percutaneous access of the collecting system.After selecting the ideal calix for puncture, the surgeon can determinethe optimal access tract using CT, ultrasound, or fluoroscopic guidance.

Fluoroscopy can optionally be performed with a single pulse or a pulserate of one pulse per second to visualize the tip of the ureteroscope.The ureteroscope is very dense and can be seen easily at even very lowmA and kVp settings. One pulse per second is significantly lower thanthe conventional pulse rate, which can be about 25 to about 30 pulsesper second.

In certain aspects, after the calix that provides the best access to thekidney has been selected ureteroscopically, ultrasound can be used tomap out the pleura, lung, and intra-abdominal organs. Assuming thatthere are no organs in the way and that the lung is a safe distance awayfrom the puncture site, the needle can be inserted directly underultrasound guidance into the desired calyx. In some configurations, theneedle can be between 14 and 25 gauge, e.g., between about 18 gauge and20 gauge. In another approach, the needle can be passed into the desiredcalyx using a “free hand” approach or the needle could be directed usinga guide that directs the needle into the desired calyx and is attachedto an US probe, CT scanner, or MRI scanner. For example, a specialinstrument can be used to provide an acoustically dense image tosimplify targeting under US guidance. As shown in FIG. 1, thisacoustically dense structure could be a balloon catheter 2 configuredfor identification under ultrasound. The balloon 4 can be inflated withair or ultrasonic contrast material or alternatively with saline toprovide a fluid filled target.

The balloon catheter 2 can be configured for insertion through aflexible ureteroscope channel. The balloon catheter shaft 6 can bebetween about 0.5 F and about 3.3 F. In certain aspects, the shaft canbe about 2.2 F. The balloon can be made of a strong and expandablepolymer, such as silicone, latex, vinyl, Gore-Tex®, or any otherexpandable coverings. The balloon material could be acoustically similarto saline or could be acoustically dense to provide a dense target. Oncethe needle has been inserted into the calyx, the balloon can be deflatedand removed through the ureteroscope. In some embodiments, a ureteralaccess sheath can be placed and then the balloon can be removed with theureteroscope through the ureteral access sheath.

In certain aspects, the acoustically dense instrument can be a basketcatheter. FIG. 2 illustrates an exemplary basket catheter 10 designed tocreate an acoustic interface. The basket 12 can be formed from anacoustically dense material or metal, such as Nitinol. In an expandedconfiguration, the basket 12 can form, for example, a large open spherehaving an expanded diameter between about 1 mm and about 20 mm. Incertain aspects, the expanded diameter can be about 10 mm. In someconfigurations of this device, a small gauge wire can be insertedpercutaneously, directly into the basket 12 under ultrasound guidanceand then the basket 12 can close over the wire to allow the wire to bepulled into the proximal ureter. Once the small wire is in the proximalureter, past the stone, a sheath can be inserted over the wire to allowconversion to a larger 0.035 or 0.038 guide wire for subsequentdilation.

In some methods, the respirations can be paused by the anesthesiologistafter a period of hyperventilation. For example, the respirations can beroutinely paused during end expiration to move the lungs as far away aspossible from the site of needle access. As another example, therespirations can be held during other parts of the respiratory cycle,for example, during inspiration to move the kidney below the rib.

In another embodiment of this technique, fluoroscopy can be used to helpdirect the needle into the desired calyx instead of using Ultrasound. Anexternal instrument can be used to provide an obvious target to assistin targeting the correct calix and positioned on the skin in the path ofthe fluoroscopy beam such that the beam would align with the tool on theskin and the calyx desired for puncture.

Using a C-arm placed at about 0 to about 45 degrees of oblique rotation,or between about 15 degrees and about 30 degrees of oblique rotation,such as about 30 degrees, the surgeon can use a heavy clamp to determinethe skin site that will lead to the desired trajectory for PCNLinsertion. For example, after using the C-arm to generate an x-ray imageand identifying the target location based on the image, the surgeon canmark the target using a clamp or other dense, metal instrument. Use ofthe instrument to mark the target access position is optional.

As shown in FIG. 8A, the C-arm 202 can include a laser guide 204attached to the head of the C-arm beam. The laser guide can beconfigured to facilitate the alignment and insertion of the needle 208(see FIGS. 8B-8D) without fluoroscopy or with decreased fluoroscopy andwithout other image guidance. The surgeon can direct the laser guide 204at the desired needle-insertion angle, for example, in line with the tipof the clamp or other marker on the skin and the ureteroscope inside thedesired calix selected for puncture. The desired needle-insertion anglecan be at least about 0 degrees and/or less than or equal to about 45degrees relative to the vertical axis L-L, for example, between about 0degrees and 30 degrees or between 15 degrees and 45 degrees, such asabout 30 degrees.

After the laser beam 206 is directed at the desired access location andangle, the needle hub 210 can be aligned with the laser 206 (see FIG.8B). Once the needle hub 210 is aligned with the laser 206, such thatthe needle hub 210, needle tip 212, and ureteroscope tip (not shown)within the kidney 200 form a single point trajectory on the C-arm 202(see FIG. 8C), the surgeon can insert the needle 208 without anyfluoroscopy activation or with greatly minimized fluoroscopy exposureused only to adjust for slight variations in respiratory excursion (seeFIG. 8D). As shown in FIG. 8C, the laser 206 can be centered on the hub210 of the needle, such that the hub 210 is illuminated, ensuring thatthe needle 208 is inserted at the appropriate trajectory. The depth ofinsertion can be determined based on a pre-operative CT scan orultrasound measurements where the depth from the skin to the desiredcalix was measured. Alternatively, the desired depth of insertion can bemarked on the needle 208 based on the initial images of the target usinga mark or removable clip, tape or bracket. This bracket could beattached to the needle reversibly so that the needle would be insertedthe desired depth, on the desired trajectory as directed by the laserbeam. Once at the desired depth the bracket could be removed.

Once the needle 208 has been inserted, the C-arm 202 can be rotated andactivated with a single pulse to confirm the depth of the needle. TheC-arm 202 can be rotated to an angle relative to the vertical axis L-Lthat is on the opposite side of the vertical axis L-L from the needleinsertion angle. The angle can be equal to the needle insertion angle.For example, if the desired insertion angle is about 30 degrees, theC-arm 202 can be rotated 60 degrees, such that the C-arm 202 ispositioned 30 degrees relative to the vertical axis L-L opposite theneedle insertion angle. Usually if the C-arm image intensifier isrotated 30 degrees toward the surgeon, the depth is checked by rotatingthe image intensifier to 30 degrees away from the surgeon. Additionallyor alternatively, the surgeon can judge the depth by watching theureteroscope image to determine under direct vision when the needleenters the collecting system.

With the needle in place, a wire can be passed from the insertion needleinto the collecting system. The direct endoscopic vision of the internaltip of the needle can facilitate placement of the guide wire.

In certain aspects, an end of the guide wire can be grasped with abasket passed in a retrograde fashion through the ureteroscope and usedto grasp the guide wire as described above. This basket can be used topull the wire down the ureter to establish through and through accessout the urethra, or alternatively to establish access only into theproximal ureter beyond the level of any stone or obstruction. The basketcan include features similar to the basket catheter shown in FIG. 2.

In certain aspects, a ureteral access sheath can be placed in aretrograde fashion using a completely fluoro-less or minimal fluoroscopytechnique. This ureteral access sheath allows the ureteroscope to bere-inserted into the kidney multiple times.

After positioning the guide wire, the guide wire can be converted to aconventional or stiff wire for subsequent dilation of the tract from theskin into the collecting system. The skin can be incised with a scalpelto the desired size depending on the size of the sheath employed fordilation. Next, the dilating balloon or serial dilation device can beplaced at the correct depth using the ureteroscope under direct visionto avoid the use of fluoroscopy.

The ureteroscope would be used to watch the tip of the balloon catheterenter the collecting system of the kidney and then to position thedilating balloon or serial dilator so that the maximal dilation occursjust inside the edge of the caliceal collecting system. The correctdepth could be determined on the first dilator if serial dilation wasgoing to be performed and this depth used to insert the subsequentdilators using a bracket, using preplaced markings placed upon thedilators or a mark placed upon the dilators during surgery. If a balloonis used for dilation, the balloon can then be inflated to theappropriate pressure for full dilation, and the sheath can be placedinto the kidney under direct ureteroscopic visualization. Alternatively,fluoroscopy could be used to position the sheath in a conventionalmanner or using a dramatically reduced fluoroscopic technique.

With the correct position of the sheath confirmed ureteroscopically, theprocedure to remove the stone can commence in the standard fashion.Flexible and rigid nephroscopy accompanied by use of ultrasound, laser,and/or basketing can be used to remove the stone fragments. At theconclusion of the procedure, the kidney can be evaluated by flexiblenephroscopy and ureteroscopy to confirm the absence of residualfragments. Intraoperative ultrasound can also be used to look forresidual stones.

After the removal of all stones, a single pulse of conventionalfluoroscopy can be used to ensure complete fragment removal. This stepcan be omitted if the surgeon is sure there are no residual fragmentsfollowing endoscopic renal mapping. Alternatively, renal ultrasoundcould be used to look for residual fragments.

If a tubeless technique is desired, the surgeon can remove all the tubesat the conclusion of the procedure. Alternatively, the surgeon can placean 8 or 10 French nephrostomy, or a 16, 18, or 22 F council-tippedcatheter with a 5 French re-entry catheter inside the renal tract toallow for renal drainage and reentry at a later time if desired. Thesetubes can be placed entirely without image guidance using direct visionby the ureteroscope or with minimal use of single pulse fluoroscopy. Inanother option, the ureteral catheter could be placed into the kidneyfrom above while monitoring the position of the proximal end of thecatheter using a flexible nephroscope placed through the percutaneousaccess site.

In some methods, a ureteral stent (e.g., a multi-length stent betweenabout 22 and about 32 cm long and/or about 6 FR) could be passed over aguide wire that was placed into the bladder using an angle tipped guidewire and a 4 FR glide catheter. In another configuration, the 0.038guide wire can be used to insert the stent. The length of the stent canbe calculated using a novel technique determining the ureteral lengthusing the Pythagorean Theorem where ureter length is calculated bymeasuring the known coronal ureter length, left to right length, andanterior/posterior length. Alternatively, the length can be estimated bycounting the number of axial slices on the CT scan and multiplying bythe slice reconstruction and adding 20%. In this technique, the fixedlength stent would be placed into the ureter from above and the stentwould be advanced until the markings showing the location for the UPJwas identified. The distal stent coil in the bladder could be confirmedwhen the ureteroscope was pulled down into the bladder.

In certain aspects, an end-hole catheter can be placed cystoscopicallyinto the ureter and used to inject diluted contrast into the collectingsystem of the kidney ranging from 1-99% dilution depending upon thedesired density of the contrast. The desired calix can be selected usingfluoroscopy and any of the previously described techniques mentioned inthe preceding description could be used for establishing access into thekidney. For example, the C-arm can be rotated laterally between about 20and about 30 degrees. The C-arm, clamp tip, and desired calix can bealigned, and the laser guide can be placed in the center of the needlehub and used to insert the needle in a steady controlled fashion. Usingthis technique, the surgeon can use his hands with no concern ofradiation exposure since the laser guide is used to direct the needle.Aspiration of fluid or air can be used to confirm appropriatepositioning in the calix. Thereafter, a lubricious wire can be fed downthe ureter using minimal use of low-dose pulsed or conventionalfluoroscopy.

In certain aspects, an ultrasound machine can be used to selectpercutaneously the appropriate desired posterior calix for access. Thelaser guide can be positioned in line with the access of the ultrasoundguide. Alternatively, a separate laser guide can be lined up with theaxis of the ultrasound guide for insertion of the probe.

In certain aspects, a laser guide can be placed on the CT scanner or CTfluoroscopy machine and the axis of the needle tract can be positionedin line with the laser as directed by the CT scanner.

In certain aspects, the laser guide can be placed on a CT scanner and aspecial non-ferromagnetic needle can be used for placement using CTfluoroscopy.

At various points of the procedure, fluoroscopy can be performed with asingle pulse or a pulse rate of one pulse per second to visualize thetip of the ureteroscope, needle, and/or guide wire. This pulse rate isstill significantly lower than the conventional pulse rate, which can beabout 25-30 pulses per second. Using this technique, a surgeon canreduce the fluoroscopy time from an average of about 6 to about 7minutes per procedure to less than about one minute. In certain aspects,the total fluoroscopy time can be between less than or equal to aboutten seconds, less than or equal to about three seconds, or less than orequal to about 1 second, thus reducing the risk of cancer dramaticallyfor the patient, surgeon and staff by dramatically reducing theradiation exposure.

Needle

FIG. 3-4 illustrates an exemplary embodiment of a needle assembly 30configured for use with the methods described above. The needle 32 candefine a lumen through which a stylet 38 can optionally extend. Thestylet 38 can include a sharpened distal end to facilitate percutaneousaccess. The needle 32 can define a blunt distal tip 36 to avoidinadvertent injury after removal of the stylet. Although, in someembodiments, the distal tip of the needle 36 can be sharpened.Optionally, the tip 36 of the needle 32 and/or stylet 38 can be etchedto create a prominent acoustic signal on ultrasound. In someembodiments, at least a portion of the needle 32 proximal to the tip 36can have a square shape to increase the acoustic prominence of theneedle (not shown).

A proximal portion of the stylet 38 can have a hub 34. The hub 34 can bedisc-shaped (see FIG. 3) or have a greater depth (e.g., similar to mainbody 102 of FIG. 11). As shown in FIG. 4, an upper surface of the hub 34can include a number of concentric rings 40 (e.g., two, three, or more)to help the surgeon accurately position the light source (e.g., laser).In some embodiments, at least a portion of the hub 34 (e.g., an outerportion of the hub 34 or the entire hub 34) can be formed from anon-opaque material (e.g., transparent or translucent material). Forexample, an outer portion of the hub 34 can be formed from a transparentmaterial and a central portion of the hub 34 can be formed from anopaque material to help center the laser. In some embodiments, the hub34 can include a diameter between about 1 cm and about 5 cm, e.g., about2 cm.

The distance between each ring 40 placed on the surface of the needlestylet hub 34 can be at least about 1 mm and/or less than or equal toabout 10 mm, e.g., about 5 mm. The distance between each ring can besubstantially the same or vary.

As shown in FIG. 4, the hub 34 can include a crosshatch 42 to help theuser identify the central axis of the needle assembly 30. In certainaspects, the distance between the central axis C and an end of thecrosshatch 42 can be between about 0.5 mm and 5.0 mm, or between about1.0 mm and about 2.0 mm. In certain aspects, the distance between thecentral axis C and an end of the crosshatch 42 can be about 2 mm, orabout 1.5 mm.

Depending on the requirements of the procedure, the needle 32 caninclude a length of at least about 5 cm, at least or about 10 cm or lessthan or equal to about 20 cm. In certain aspects, the needle 32 caninclude a length between about 5 cm and about 20 cm, e.g., about 10 cm,about 15 cm, or about 20 cm. In certain aspects, the needle 32 can be aslarge as 12 gauge and/or less than or equal to about 25 gauge, e.g.,about 18 gauge. The needle 32 can define a lumen configured to allow thepassage of a wire between about 0.18 gauge and about 0.38 gauge, e.g.,about 0.25 gauge.

In certain embodiments, the hub 34 can be transparent or translucent andinclude an opaque channel (not shown). For example, the opaque channelcan be centrally disposed in the hub 34. An upper surface of the hub 34can include an opening that would allow the passage of the light sourcethrough the opaque channel when the opaque channel is aligned with thelight source. In some embodiments, the opaque channel can be betweenabout 0.1 mm wide and about 2 mm wide. In some embodiments, the opaquechannel can have a length between about 1 mm and 5 cm. The length towidth ratio would be such that the angle that the needle 32 coulddeviate from the axis of the light source and still produce theillumination of the glowing hub portion 34 of the needle 32 would be avery small angle, e.g., between about 0.1 and 10 degrees, such as about2 degrees, and preferably less than 1 degree. In some embodiments, theopaque channel can be lined with one or more reflectors. Thesereflectors can be constructed from metal, glass, mirrors or anyreflective material that can reflect light toward the light source whenthe light source is not aligned with the opaque channel so that no lightenters the transparent or translucent portion of the hub 34. If thesurgeon visualizes the feedback of the light reflected back out of theopaque channel, the surgeon would recognize that the orientation of theneedle 32 is not correct. In some embodiments, the core of the channelcould be lined with a wound metal spring that could reflect the lightback out when not correctly aligned as described above.

In certain variants, the needle assembly 30 can include no stylet 38.The distal end 36 of the needle 32 can include a sharpened end, and thehub 34 described above can connected to a proximal end of the needle 32.

FIGS. 9 and 9A illustrate an exemplary embodiment of a percutaneousaccess needle assembly 100 that can be used with the methods describedabove. As described above, a laser can facilitate insertion and removalof the needle assembly 100 at the correct position and correct angle.When the needle assembly 100 is positioned correctly, the main housing102 of the needle assembly 100 can light up to indicate proper alignmentwith a light source (see FIG. 9). Use of the light source and needleassembly 100 to position the needle can reduce the total amount offluoroscopy time by at least 50%.

As shown in FIGS. 10 and 11, the needle access assembly 100 can includea trocar needle 108 axially movable through a cannula 104 (see FIGS.18A-18C). The trocar needle 108 can include a main housing 102 and aneedle 105 extending from the main housing 102. In some embodiments, theneedle 105, which is sharpened to allow for easy insertion, canoptionally be detached from the trocar needle 108. For example, theneedle 105 can connect directly or indirectly to the main housing 102using a snap fit, friction fit, screw fit, adhesive, or other suitableconnection. Further, the trocar 108 can optionally include an engagementfeature 106 (see FIGS. 10 and 11) that can removably engage acorresponding engagement feature 103 of the blunt hollow needle cannula104. For example, the needle assembly 100 can include a luer connectorat a distal end of the main body 102. The luer connector 106 of theneedle assembly 100 can engage a corresponding luer connector positionedat a proximal end of the cannula 104. Other connections are alsoimaginable, such as screw fit, a friction fit, a snap fit, or otherwise.

As shown in FIG. 12, the trocar 108 can include a cap 101 through whicha laser or other light source can be shined through an opening 110 toprovide guidance for percutaneous access. The cap 101 can be opaque andcan have the narrow, centrally disposed opening 110 extending throughthe cap 101. The opening 110 can have a diameter that is less than adiameter of the main body 102 (e.g., less than about 50%, less thanabout 40%, less than about 30%, less than about 20%, less than about10%, or values in between). In some embodiments, the opening 110 can beoptionally filled with a transparent material. In some embodiments, thecap 101 can optionally include a concentric circle pattern similar tothe pattern described in connection with FIG. 4 to facilitate thepositioning of the laser.

To facilitate visualization of the illuminated main body 102, the mainbody 102 can include a diameter of at least about 1 inch, at least about2 inches, or preferably at least about 3 inches. In some embodiments,the main body 102 can be constructed from an opaque material, and theuser can rely on alignment between the light source and opening 110 forvisual indication of proper alignment. In some embodiments, the mainbody 102 can be constructed from a transparent or translucent materialso that users can visualize the light source shining through the mainbody 102. Since the cap 101 is opaque, the main body 102 will onlyilluminate if the laser is aligned with the opening 110. This ensuresthat that the main body 102 is not illuminated when the laser enters themain body 102 but at an incorrect angle.

In some embodiments, the cap 101 can removably engage the main body 102.For example, the cap 101 can threadably engage the main body 102, suchthat the cap 101 fits into (see FIG. 12) and/or surrounds (see FIGS.14A-14C) the main body 102. As another example, the cap 101 can engagethe main body 102 using a snap fit (not shown) such that the cap 101fits into and/or surrounds the main body 102. Alternatively, as shown inFIGS. 15A-15D, the cap 101 and main body 102 can be integrally formed.

As shown in FIGS. 13A and 13B, the main body 102 of the trocar 108 canoptionally include a light enhancement feature for propagating light. Insome embodiments, as shown in FIG. 13A, a reflective plate, reflectingcoating, otherwise reflective surface 111 can be provided within aninterior space of the main body 102. In some embodiments, as shown inFIG. 13B, a dome reflector 112 can be positioned within the main housing102. As shown in FIG. 16, when the needle access assembly 100 is alignedwith the light source 114, the light enhancement feature can propagatelight 116 such that there is clear visual indication of properalignment. In contrast, as shown in FIG. 17, when the needle accessassembly 100 is not properly aligned with the light source 114, littleor no light can be seen from the main housing 102.

Although not shown, in some embodiments, the needle access assembly 100can include a camera to provide direct visualization during insertion.In some embodiments, the needle access assembly 100 can include sensorsin a 3D array to provide real time data on 3D movement of the needleaccess assembly 100.

Training Model

FIGS. 5-7 illustrate a training model 50 for training users how toobtain percutaneous access using the above-described technique. Themodel 50 can include one or more layers 52 designed to replicate theorgans, muscle, fat, and skin. FIGS. 5-7 specifically illustrate a model50 for the kidney collecting system, but similar materials can be usedto construct a model for other areas of the body.

The model 50 can include one or more layers designed to replicate theskin. The skin layers can include, but are not limited to, carpetpadding, plastic, or silicone. The deep muscles and perinephric fat canbe replicated using gelatin, silicone, or any polymer or substance thatwill permit shaping into the desired shape. The model collecting system56 can be replicated using a latex or any type of glove. The fingers 58can be tied off to create the calices, and tape can be applied to theinnermost portions of the fingers to create the narrowing of theinfundibula. The palm of the glove 60 can be narrowed by tying or usingtape to create a renal pelvis. The palm of the glove 60 can be connectedto a penrose drain 62 to establish the ureter. The model kidney 54 canbe replicated by forming reniform shape from a gelatin, soft plastic,silicone, or other soft material. The kidney material can be made ofclear material to allow an observer to determine if the trainee hadplaced the needle into the appropriate calix by visual inspection fromunderneath a glass surface. In some embodiments, the model 50 couldinclude a small camera on the inside to simulate the image provided bythe ureteroscope and to allow the trainee to learn how the internalimage may assist in correct placement of the needle.

The layers 52 can be mounted on a surface constructed from a clearmaterial, for example, plexiglass. One or more holes can be formed inthe clear surface. Each of the holes can receive a bolt or otherstructure to secure and align each of the layers to the clear surface.

The model can be positioned on the cut out portion of the fluoroscopytable, so the observer can easily see if the needle had been placed intothe appropriate calix by direct observation. An open-ended catheter canbe used to create the contrast used for injection if the training wouldlike to focus on learning the fluoroscopy guided laser DARRT technique.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, and/or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, and/or steps are inany way required for one or more embodiments, whether these features,elements, and/or steps are included or are to be performed in anyparticular embodiment.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, the terms“approximately”, “about”, and “substantially” may refer to an amountthat is within less than 10% of, within less than 5% of, within lessthan 1% of, within less than 0.1% of, and within less than 0.01% of thestated amount.

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of themethods and devices shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure. Awide variety of designs and approaches are possible. No feature,structure, or step disclosed herein is essential or indispensable.

Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, it will berecognized that any methods described herein may be practiced using anydevice suitable for performing the recited steps.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the disclosure may be embodied or carried out in a mannerthat achieves one advantage or a group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

Moreover, while illustrative embodiments have been described herein, thescope of any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. The limitations in theclaims are to be interpreted broadly based on the language employed inthe claims and not limited to the examples described in the presentspecification or during the prosecution of the application, whichexamples are to be construed as non-exclusive. Further, the actions ofthe disclosed processes and methods may be modified in any manner,including by reordering actions and/or inserting additional actionsand/or deleting actions. It is intended, therefore, that thespecification and examples be considered as illustrative only, with atrue scope and spirit being indicated by the claims and their full scopeof equivalents.

Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “aligning a needle with a light source” include“instructing alignment of a needle and a light source.”

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between” and the like includes thenumber recited. Numbers preceded by a term such as “about” or“approximately” include the recited numbers. For example, “about 3 mm”includes “3 mm.”

Example Embodiments

The following example embodiments identify some possible permutations ofcombinations of features disclosed herein, although other permutationsof combinations of features are also possible.

1. A needle access device configured for insertion into a patient withreduced fluoroscopy, the device comprising:

a needle connected to a hub portion, the hub portion comprising:

-   -   an opaque cap portion;    -   a non-opaque body portion positioned between the opaque cap        portion and the needle; and    -   a channel extending through the opaque cap portion, the channel        positioned such that the non-opaque body portion only        illuminates when a light source is aligned with the channel

2. The needle access device of Embodiment 1, wherein the channel has adiameter that is less than or equal to an outer diameter of the needle.

3. The needle access device of Embodiment 1 or 2, wherein the hubportion comprises a reflective surface positioned in the non-opaque bodyportion.

4. The needle access device of Embodiment 3, wherein the reflectivesurface comprises a reflective material.

5. The needle access device of Embodiment 3, wherein the reflectivesurface comprises a dome reflector.

6. The needle access device of any one of Embodiments 3 to 5, whereinthe reflective surface is positioned across a transverse plane of thehub portion.

7. The needle access device of any one of the preceding Embodiments,further comprising at least two concentric circles disposed on aproximal end of the hub portion.

8. The needle access device of any one of the preceding Embodiments,further comprising a crosshatch disposed on a proximal end of the hubportion.

9. The needle access device of any one of the preceding Embodiments,wherein the hub portion further comprises a luer connector configured toconnect to a cannula.

10. The needle access device of any one of the preceding Embodiments,wherein the opaque cap portion is removably secured to the non-opaquebody portion.

11. The needle access device of Embodiment 10, wherein the opaque capportion is threadably secured to the non-opaque body portion.

12. The needle access device of any one of the preceding Embodiments,wherein an inner diameter of the non-opaque body portion is larger thana diameter of the channel

13. The needle access device of any one of the preceding Embodiments,wherein an outer diameter of the non-opaque body portion is at least twotimes larger than an outer diameter of the needle.

14. The needle access device of any one of the preceding Embodiments,wherein an outer diameter of the non-opaque body portion is at leastfive times larger than an outer diameter of the needle.

15. The needle access device of any one of the preceding Embodiments,wherein the non-opaque body portion is transparent.

16. The needle access device of any one of Embodiments 1 to 15, whereinthe non-opaque body portion is translucent.

17. A method of obtaining percutaneous needle access:

selecting a calix for percutaneous access;

positioning a flexible ureteroscope in the selected calix;

directing a light source at a desired needle-insertion angle and in linewith a tip of the ureteroscope;

aligning the needle access device of any one of Embodiments 1 to 16 withthe light source and the ureteroscope tip; and

inserting the needle access device into the selected calix.

18. The method of Embodiment 17, further comprising delivering aninstrument through the ureteroscope, the instrument configured tofacilitate the insertion of the needle through the selected calix.

19. The method of Embodiment 18, wherein the instrument is identifiableunder ultrasound.

20. The method of Embodiment 18 or 19, wherein the instrument is aballoon catheter.

21. The method of Embodiment 18 or 19, wherein the instrument is abasket catheter.

22. The method of any one of Embodiments 17 to 21, further comprisingapplying fluoroscopy for less than ten seconds.

23. The method of any one of Embodiments 17 to 22, wherein aligning theneedle access device with the light source comprises illuminating a hubportion of the needle access device.

24. The method of Embodiment 23, wherein illuminating the hub portion ofthe needle access device comprises reflecting the light source from areflective surface within the hub portion.

25. The method of any one of Embodiments 17 to 24, wherein the lightsource is a laser beam.

26. The method of any one of Embodiments 17 to 25, wherein inserting theneedle access device into the selected calix comprises advancing theneedle through a cannula.

1-10. (canceled)
 11. A method of obtaining percutaneous needle accessinto a patient, the method comprising: selecting a site for percutaneousaccess; directing a light source at a desired needle-insertion angle andin line with the site; aligning a needle access device with the lightsource, the needle access device comprising: a needle; an opaqueproximal cap portion comprising an axial opening through the capportion, the axial opening having a first diameter; a non-opaque mainbody portion positioned between the cap portion and the needle, the mainbody portion having an interior space forming a hollow innerillumination chamber having a second diameter greater than the firstdiameter of the axial opening, the illumination chamber comprising adistal wall portion and a translucent wall portion through which thelight source can be visualized; and a proximal-facing, interior surfacewithin the hollow illumination chamber of the main body portion andproximal to the distal wall portion of the illumination chamber, theinterior surface comprising a convex reflective surface configured toreflect and scatter light from the light source throughout the entireillumination chamber when the light source is axially aligned with theneedle and the opening in the cap portion; and inserting the needleaccess device into the selected site, wherein inserting the needleaccess device comprises: aligning the opening of the cap portion withthe light source such that the light source is reflected and scatteredwithin the illumination chamber so as to be visible through thetranslucent walls of the main body portion.
 12. The method of claim 11,wherein the light source is a laser.
 13. The method of claim 11, furthercomprising decoupling the main body portion from the needle.
 14. Themethod of claim 11, further comprising: positioning a flexible endoscopein the selected site; detecting a position of a tip of the flexibleendoscope; and marking on a skin of the patient a location correspondingto the position of the tip of the flexible endoscope.
 15. The method ofclaim 14, wherein marking comprises positioning a heavy clamp, a tool,or a radiopaque device on the skin of the patient at the locationcorresponding to the position of the tip of the flexible endoscope. 16.The method of claim 14, wherein the endoscope comprises a ureteroscopeand the selected site comprises a calyx.
 17. The method of claim 14,further comprising delivering an instrument through the endoscope. 18.The method of claim 17, wherein the instrument is identifiable underultrasound or easily seen at low mAs or kVp settings under fluoroscopy.19. The method of claim 18, wherein the instrument comprises anexpandable member.
 20. The method of claim 18, further comprising:passing a guidewire through the needle to the site; capturing theguidewire with a basket passed retrograde through the endoscope; andpulling the basket to bring the guidewire down to establish through andthrough access
 21. The method of claim 14, further comprising insertinga wire through the needle.
 22. The method of claim 21, furthercomprising: advancing a basket catheter through the flexible endoscope,the basket catheter comprising a basket configured to move between anexpanded configuration and a constrained configuration; inserting thewire through an opening formed by the basket in the expandedconfiguration; moving the basket from the expanded configuration to theconstrained configuration; and pulling the wire with the basketcatheter.
 23. The method of claim 11, further comprising applyingfluoroscopy for less than one minute.
 24. The method of claim 11,further comprising applying fluoroscopy for less than ten seconds. 25.The method of claim 11, further comprising inserting the needle througha cannula.
 26. The method of claim 25, further comprising withdrawingthe needle from the cannula after inserting the needle into the selectedsite.